FAQS

Basic Information

1. Why is there a notice?

This lawsuit has been approved by the Court to proceed as a class action against St. Jude for the purpose of effecting the Settlement Agreement reached between the parties. If you are included in the Class, this Notice explains your legal rights.

2. What are the Settlement benefits?

If the Court approves the Settlement Agreement, St. Jude will pay $5,000,000.00 CAD in full and final settlement of all claims in the class action against it, including Class Counsel’s fees and administration costs, in return for releases and a dismissal of the class action. The Settlement Fund, less administration costs and lawyers’ fees, will be distributed to the Class in accordance with the Court-approved and supervised Distribution Protocol, which can be reviewed at Schedule G of the Settlement Agreement found here.

The Distribution Protocol anticipates that the Settlement Fund will be paid on the following basis:

  • An amount for each Eligible Explant Claimant, depending upon a number of factors, including the number of Eligible Explant Claimants, the number of claimants who have experienced complications arising from surgery to replace their Defibrillator, and total valid claims;
  • Additional compensation for Eligible Explant Claimants who have experienced complications arising from surgery to replace a Defibrillator as awarded by the Referee in accordance with guidelines approved by the Court;
  • Up to $100.00 CAD to those Patient Class Members who
    (i) had their Defibrillator implanted prior to December 1, 2013; and
    (ii) are not an Eligible Explant Claimant;
  • Up to $500.00 CAD to those Patient Class Members who
    (i) had their Defibrillator implanted on or after December 1, 2013; and
    (ii) are not an Eligible Explant Claimant;
  • Payments to the Derivative Class Members of deceased Patient Class Members as approved by the Referee in accordance with guidelines approved by the Court; and
  • Out of pocket expenses, up to $500.00 CAD, incurred by Class Members in the amounts approved by the Referee in accordance with guidelines approved by the Court.

“Eligible Explant Claimants” means Patient Class Members who either (i) had a Defibrillator replaced due to premature battery depletion where the battery depletion occurred earlier than expected based on the Defibrillator usage and there was no indication that the depletion was related to a cause other than a short circuit that may have been due to the formation of lithium clusters, or (ii) had a Defibrillator replaced between October 10, 2016 and August 8, 2017on an elective basis in response to the St. Jude advisory issued in Canada on October 10, 2016 provided that the electively replaced Defibrillator had been implanted for less than five years at the time of the replacement.

3. What is this class action about?

In 2017, a class action was commenced by Shirley Houle and Roland Houle of Port Hope, Ontario, (the Representative Plaintiffs) against St. Jude Medical, Inc. and St. Jude Medical Canada, Inc. (together, “St. Jude” or the “Defendants”), in the Ontario Superior Court of Justice. The settlement does not constitute an admission of liability, but represents a negotiated compromise of disputed allegations and claims.

In the action, the Plaintiffs assert that the batteries in certain models of Defibrillators that were manufactured by the Defendants between January 2010 and May 23, 2015 were faulty as they were subject to forming lithium clusters that could cause the batteries to prematurely deplete, and that the Defendants allegedly failed to warn the Class about this defect in a timely manner.

On August 1, 2019 the Ontario Superior Court of Justice approved the settlement.

St. Jude has agreed to pay the all-inclusive amount of $5,000,000 CAD (the “Settlement Fund”) to settle the class action, in return for releases and a dismissal of the class action. The Settlement Fund includes $750,000 CAD for court costs, which will be allocated towards Class Counsel’s legal fees. The Court has approved payment of Class Counsel’s legal fees and disbursements inclusive of HST in the amount of $1,371,675.00. The fees are 27% of the Settlement Amount, exclusive of the court costs paid by St. Jude. These amounts will be deducted from the Settlement Fund.

4. Which Defibrillators are involved under this class action?

Trade NameModelTrade NameModel
Fortify Assura™ DRCD2259-40QQuadra Assura MP™CD3371-40C
Fortify Assura™ DRCD2259-40Quadra Assura MP™CD3371-40QC
Fortify Assura™ DRCD2359-40CQuadra Assura™CD3265-40Q
Fortify Assura™ DRCD2359-40QCQuadra Assura™CD3367-40QC
Fortify Assura™ VRCD1359-40QCQuadra Assura™CD3267-40
Fortify Assura™ VRCD1259-40Quadra Assura™CD3267-40Q
Fortify Assura™ VRCD1259-40QQuadra Assura™CD3367-40C
Fortify Assura™ VRCD1359-40CUnify Assura™CD3261-40Q
Fortify™ DRCD2233-40QUnify Assura™CD3361-40QC
Fortify™ DRCD2233-40Unify Assura™CD3261-40
Fortify™ ST DRCD2235-40Unify Assura™CD3361-40C
Fortify™ ST DRCD2235-40QUnify Quadra™CD3251-40
Fortify™ ST VRCD1235-40Unify Quadra™CD3251-40Q
Fortify™ ST VRCD1235-40QUnify™CD3231-40
Fortify™ VRCD1233-40Unify™CD3235-40
Fortify™ VRCD1231-40Unify™CD3235-40Q
Fortify™ VRCD1233-40Q

5. What are the plaintiffs asking for?

The proposed class action asks for money for Class Members for physical and psychological injuries as a result of St. Jude allegedly failing to warn that the batteries in the Defibrillators were subject to forming lithium clusters that could cause the batteries to prematurely deplete. The Representative Plaintiffs are also asking for an honorarium of $5,000.00 CAD each, payment of their lawyers’ fees and costs, the costs of administering the settlement.

6. Is there any money available now?

On August 1, 2019 the Ontario Superior Court of Justice approved the settlement.

St. Jude has agreed to pay the all-inclusive amount of $5,000,000 CAD (the “Settlement Fund”) to settle the class action, in return for releases and a dismissal of the class action. The Settlement Fund includes $750,000 CAD for court costs, which will be allocated towards Class Counsel’s legal fees. The Court has approved payment of Class Counsel’s legal fees and disbursements inclusive of HST in the amount of $1,371,675.00. The fees are 27% of the Settlement Amount, exclusive of the court costs paid by St. Jude. These amounts will be deducted from the Settlement Fund.

The Settlement Amount of $5,000,000.00 CAD, less administration costs and lawyers’ fees, and any honorarium to the representative plaintiffs, as approved by the Court, will be distributed in accordance with the Court-approved and supervised Distribution Protocol.

The deadline to submit a claim for benefits is 11:59 pm EST on January 10, 2020. Click here to submit a claim.

7. Who are the Patient Class Members?

Patient Class Members are all persons who are resident in Canada and were implanted in Canada with one or more of the Defibrillators listed on the Patient Claim Form or FAQ#4.

8. Who are the Derivative Class Members?

Derivative Class Members are close family members of Patient Class Members such as a spouse, children, grandchildren, parents or grandparents.

All Derivative Class Members have the right to submit claims for their own out of pocket expenses that were incurred because of actions taken in response to the Health Canada Advisory published on October 10, 2016.

Only the spouse and minor children, or if there is no spouse or minor children, then adult children or parents of deceased Patient Class Members may claim death benefits if the Patient Class Member died and the death was caused by the lithium cluster issues, but only if they meet the required criteria set out in the Derivative Class Member Claim Form.

9. Can I submit a claim on behalf of someone who is deceased?

Yes, you may submit a claim on behalf a deceased Patient Class Member’s Estate only if you are the executor of the Patient Class Member’s Estate. If you are the estate executor, the Claim Form must be accompanied by a copy of the death certificate and the grant of probate or a copy of the deceased’s will.

10. How do I submit a claim on behalf of someone who is deceased?

If you are an estate executor and are making a claim on behalf of a deceased Patient Class Member, please fill out the Patient Claim Form and include the name and defibrillator information of the deceased Patient Class Member and also include your contact information. You must include proof that you are the estate executor, such as the grant of probate or a copy of the deceased’s will, in your claim package as well as a copy of the death certificate.

11. Do I need to send original documents to support my claim?

No. Please only send copies of your documentation to the Claims Administrator.

12. Where do I submit my completed Claim Form?

Please submit your claim online here

OR

Mail your completed Claim Form and supporting documentation to:

St. Jude ICD Class Action Claims Administrator
Nelson P.O. Box 20187 – 322 Rideau Street
Ottawa, ON K1N 5Y5

OR

Email your Claim Form and supporting documentation to:
info@stjudeicdclaim.ca

OR

Fax your completed Claim Form and supporting documentation to the Claims Administrator at 1-866-262-0816

Please do NOT send your Claim Form to Class Counsel.

Your Legal Rights and Options

Click here to read your Legal Rights and Options in this Settlement.

13. What happens if I do nothing at all?

If you do nothing, you automatically remain a Class Member (if you qualify) and you will be legally bound by all orders and judgments of the Court, including a release to be granted in favor of St. Jude, and you will not be able to sue St. Jude regarding the legal claims made in this case.

14. What if I do not agree with the Settlement Agreement or Class Counsel’s requested fees and disbursements?

The Settlement Agreement may be viewed here.

Once filed with the Court, the materials explaining why Class Counsel and the Representative Plaintiffs say that this settlement is in the best interests of the Class will also be posted in the Documents tab of the website. Click here.

Court documents explaining and supporting Class Counsel’s request for approval of their fees and disbursements will also be posted in the Documents tab of the website. Click here. Class Counsel entered into a contingency fee agreement with the Representative Plaintiffs that would permit Class Counsel to be paid 1/3 of the recovery achieved for the class, exclusive of any amount paid by St. Jude as a contribution to court costs. Class Counsel will be asking the Court to approve fees payable to them of no more than $1,300,000.00 CAD, plus disbursements and taxes.

On August 1, 2019, at 10 a.m. EST, the Court will hear the Representative Plaintiffs’ motion for Settlement Approval, and Class Counsel’s Motion for approval of their contingency fee agreement. The hearing will be held at Osgoode Hall, 130 Queen Street West, Toronto, Ontario.

If you want to remain in the Class, but object to the terms of the Settlement Agreement or object to the amount of fees requested by Class Counsel, you must submit your objection in writing addressed to Class Counsel at their address below. Written objections must be filed with the Court, and must be delivered no later than July 29, 2019.

You may also attend the hearing in person or with your own lawyer to raise any objection.

Objections should be sent to:

Waddell Phillips Professional Corporation
Attention: St. Jude Defibrillator Class Action
36 Toronto Street, Suite 1120
Toronto ON M5C 2C5
Fax: 416-477-1657
Email: reception@waddellphillips.ca

15. What if I want to exclude myself from the class?

If you decide that you do not want to participate in the class action, you must exclude yourself - this is referred to as “opting-out”. If you exclude yourself, you will not receive any payment or benefit from the Settlement Agreement, if it is approved. You will not be bound by any Court orders and you keep your right to sue St. Jude regarding the issues raised in this case, subject to any limitation periods that may apply. If you opt out, you cannot change your mind later and opt back into the class action.

To exclude yourself, you must submit an Opt-Out Form to the Claims Administrator no later than July 19, 2019 at:

Epiq Class Action Services
Attention: St. Jude ICD Class Action Settlement Claims Administrator
Nelson P.O. Box 20187 – 322 Rideau Street
Ottawa ON K1N 5Y5
Email: info@stjudeicdclaim.ca
Fax: 1-866-262-0816

The Opt-Out Form must include your full name, address and telephone number, as well as your Provincial Health insurance number, the make, model and serial number of your Defibrillator, the date and location where you were implanted with the Defibrillator, and, if it was explanted, the date and location of the explant surgery. If you are a family member of a deceased relative who had a Defibrillator, the Opt-Out Form must also include your relative’s date of death and an indication as to whether their death was related to premature battery depletion with the Defibrillator. You may download the Opt-Out Form here.

The Opt-Out Form must be postmarked, if sent by mail, or received, if sent by fax, email or courier, on or before July 19, 2019 at 11:59 p.m. EST. Opt-Out Forms received after this date will not be accepted or valid, and you will be remain a Class Member.

16. How do I submit a claim?

On August 1, 2019 the Ontario Superior Court of Justice approved the settlement.

The only way to receive any of the benefits under this class action settlement, is to submit a duly completed claim form online, by email, fax, or mail to the Claims Administrator, along with all required supporting documentation no later than 11:59 pm EST on January 10, 2020.

17. What type of supporting documentation is required and sufficient?

In order to receive a payment from the Settlement Fund, each Patient Class Member and Derivative Class Member must submit a claim form, and all required supporting documentation, which must be received by the Claims Administrator no later than 11:59 p.m. EST on January 10, 2020.

See the table below for required supporting documentation.

Eligible Non Explant ClaimantsSupporting Documentation Required with Claim Form
  • No documentary proof is required if you received a prefilled Claim Form and you are only claiming the “failure to warn” pro rata compensation. You need only to submit the completed Claim Form.
  • If you are claiming Out of Pocket Expenses that are related to actions that you took in response to the receipt of the St. Jude advisory released on October 10, 2016, you must provide receipts.
Eligible Explant Claimants
  • If you are an Explant Patient, supporting documentation may include Doctor, Physician, Clinical or Hospital records or notes. These can be requested by contacting your doctor, cardiac device clinic, or treating hospital. You may supplement this with a written submission in the space provided in the Claim Form.
Extraordinary Injury Fund Claimants1) Out of Pocket Claims
  • Receipts

Out of Pocket Expenses must be related to actions taken in response to the receipt of the St. Jude advisory released on October 10, 2016.

2) Payments due to Patient Class Member DeathSupporting documentation demonstrating that the death was caused or contributed to by premature battery depletion where the battery depletion occurred earlier than expected based on the Defibrillator usage and there was no indication that the depletion was related to a cause other than a short circuit that may have been due to the formation of lithium clusters. Supporting documentation includes, if necessary, medical records, an attending physician’s report, death certificate of the Patient Class Member, or such other documentation acceptable to the Referee to demonstrate that the Class Member qualifies as an Eligible Extraordinary Injury Fund Claimant.
3) Complication ClaimsSupporting documentation demonstrating that the complications arose from the explant surgery or such other documentation acceptable to the Referee to demonstrate that the Class Member qualifies as an Eligible Extraordinary Injury Fund Claimant.

The Lawyers Representing You

18. Do I have a lawyer in the case?

Yes. Waddell Phillips Professional Corporation and Howie, Sacks and Henry LLP are the lawyers for the Representative Plaintiffs, and are Class Counsel.

19. How will the lawyers get paid?

On August 1, 2019 the Ontario Superior Court of Justice approved the settlement.

St. Jude has agreed to pay the all-inclusive amount of $5,000,000 CAD (the “Settlement Fund”) to settle the class action, in return for releases and a dismissal of the class action. The Settlement Fund includes $750,000 CAD for court costs, which will be allocated towards Class Counsel’s legal fees. The Court has approved payment of Class Counsel’s legal fees and disbursements inclusive of HST in the amount of $1,371,675.00. The fees are 27% of the Settlement Amount, exclusive of the court costs paid by St. Jude.